VIC Regimen Versus Bevacizumab Plus Chemotherapy as First... | NCT05540951

Studies
VIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer

NCT05540951

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Sep 15, 2022Actual

Enrollment

78Estimated

Phase

Phase 3

Conditions

Colorectal Cancer

Interventions

VIC
Bevacizumab Plus Chemotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Sep 12, 2022

First Submission Date that Met QC Criteria

Sep 14, 2022

First Posted Date

Sep 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2022

Last Update Posted Date

Sep 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xu jianmin, Deputy director of the department of general surgery, Fudan UniversityPrincipal Investigator

Lead Sponsor

Fudan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal was to evaluate the safety of VIC regimen, and to investigate the tumor response, the radical resectability, and the patient survival.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VIC	Experimental	VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)	Drug: VIC
BEV	Active Comparator	Bevacizumab Plus Chemotherapy	Drug: Bevacizumab Plus Chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VIC	Drug	VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)	VIC
Bevacizumab Plus Chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression-free survival	time from first study treatment to the first documented progression disease or death, whichever occurred first	3 years
overall survival	time from first study treatment to death from any cause.	3 years
objective response rate	the proportion of patients with complete response or partial response.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 and ≤80 years old
Histologically confirmed colorectal adenocarcinoma
Histologically confirmed BRAFV600E mutated and RAS wild-type
Initially unresectable metastatic or local CRC
ECOG performance status of 0-1 and life expectancy ≥3 months
adequate hepatic, renal, and hematologic function

Exclusion Criteria:

Previously taken any targeted therapy, chemotherapy, intervention therapy, or radiotherapy for CRC within 6 months
Other cancers (with the exception of cervical cancer in situ and squamous cell carcinoma of the skin) within the previous 5 years.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianmin Xu, MD	Contact	86-21-6404-1990	3449	xujmin@aliyun.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of General Surgery, Zhongshan Hospital, Fudan University	Recruiting	Shanghai			China

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D004358	Drug Therapy

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided